# FDA 483 - Hospira, Inc., A Pfizer Company - September 12, 2002

Source: https://www.keypedia.com/records/483/hospira-inc-a-pfizer-company/2091e659-230d-47bd-892c-11d347ec23db

> FDA 483 for Hospira, Inc., A Pfizer Company on September 12, 2002. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc., A Pfizer Company
- Inspection Date: 2002-09-12
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Abbott Laboratories in McPherson, KS, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm lacked an adequate environmental monitoring program, failed to monitor all personnel entering aseptic processing areas daily, and had not properly evaluated airflow patterns with smoke studies for component transfer and sealing activities.

## Related Documents

- [EIR - 2014-04-23](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/cb4c5e27-0aa6-4fad-8897-5754de801d5b)
- [EIR - 2017-10-27](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/e7115820-ea8b-4be8-a8c2-e2c3b6507f59)
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- [EIR - 2016-06-08](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/cbba781c-5e68-4b37-8cbd-03176aa653f2)
- [EIR - 2011-05-05](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/d4abe4d0-8a35-45cc-95b5-74c5f5ddae08)

## Related Officers

- [Owner](https://www.keypedia.com/people/shirley-j-berryman/44c8edab-2053-4af0-84fe-146b8168cd10)
- [James I. Giefer](https://www.keypedia.com/people/james-i-giefer/8be17303-a853-44e7-948e-3db91c5924e0)

Company: https://www.keypedia.com/companies/hospira-inc-a-pfizer-company/46d63c80-caf7-40db-8325-13fcade5e82c

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79